Biofinity Sphere and Biofinity Toric (comfilcon A) Soft (Hydrophilic) Contact Lenses for Extended Wear
FDA premarket approval P080011/S106 · decided 2020-10-01
Approval details
- PMA number
- P080011
- Supplement
- S106
- Supplement type
- 135 Review Track For 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- Biofinity Sphere and Biofinity Toric (comfilcon A) Soft (Hydrophilic) Contact Lenses for Extended Wear
- Generic name
- Lenses, soft contact, extended wear
- Applicant
- CooperVision, Inc.
- Date received
- 2020-04-29
- Decision date
- 2020-10-01
- Days to decision
- 155 days
- Decision code
- APPR
- Product code
- LPM
- Advisory committee
- Ophthalmic
- Expedited review
- No
- Location
- San Ramon, CA
- Statement
- Approval for introduction of a new manufacturing line for Biofinity Sphere Minus and Biofinity Toric Minus and Plus (comfilcon A) contact lenses, and the use of alternative equipment for QC1 (in-process) measurement of sphere power, cylinder power, and axis of Biofinity Toric lenses.
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